1. Field of the Invention
The subject invention relates to a vascular introducer, and more particularly, to an introducer having multiple sheaths to facilitate sequential placement of multiple diagnostic or therapeutic surgical devices into a blood vessel.
2. Background of the Related Art
Devices for assisting the percutaneous introduction of diagnostic or therapeutic devices into the body are well known in the art. A particularly useful prior art vascular introducer is disclosed in U.S. Pat. No. 4,687,469 to Osypka. This device, which is designed to facilitate the percutaneous introduction of pacemaker electrodes and cardiovascular catheters, includes a thin-walled sheath configured to be slit open with a cutting blade for easy withdrawal.
During a surgical procedure, such as the implantation of a pacemaker electrode or defibrillation lead, it is often necessary to introduce more than one diagnostic or therapeutic device into the body. For example, it is may be necessary to introduce two or more pacemaker electrodes and a cardiovascular catheter during the same procedure. In such an instance, when using either of the prior art vascular introducers described hereinabove, after the introducer sheath has been pealed-away or slit open and withdrawn from the puncture site, a second introducer must be percutaneously advanced into the desired area to facilitate the introduction of a second medial device. This can cause undue trauma to the blood vessel.
It would be beneficial therefore, to provide a vascular introducer configured to facilitate the placement of more than one diagnostic or therapeutic device into the body during a surgical procedure.
The subject invention is directed to a vascular introducer that is adapted and configured to facilitate percutaneous placement of several diagnostic or therapeutic surgical devices into a blood vessel during a surgical procedure, including, for example, a pacemaker lead and a cardiovascular catheter, or two or more pacemaker leads. The introducer includes an elongated primary sheath defining an interior lumen and having opposed proximal and distal end portions, and at least an elongated secondary sheath disposed within the interior lumen of the primary sheath. The secondary sheath is adapted for movement from a collapsed condition, wherein the sheath assumes a generally arcuate or concave configuration, to an open condition in response to insertion of a dilator through an interior lumen thereof.
The introducer may further comprise an elongated tertiary sheath that can be disposed within the interior lumen of the primary sheath or within the interior lumen of the secondary sheath. Those skilled in the art will readily appreciate that the introducer of the subject invention can be provided with more than three sheaths, as the wall thickness of each sheath is relatively thin. It is envisioned that the interior lumen of each sheath can have a different (i.e., smaller and larger) or similar diameter so as to accommodate different or similar surgical devices.
In a preferred embodiment of the subject invention, the vascular introducer includes an elongated primary sheath defining an interior lumen and having opposed proximal and distal end portions, at least an elongated secondary sheath disposed within the interior lumen of the primary sheath and adapted for movement from a collapsed condition to an open condition, and an elongated dilator configured for reception within the interior lumen of the primary sheath and adapted for insertion through the interior lumen of the secondary sheath to effectuate movement of the secondary sheath from the collapsed condition to the open condition.
Preferably, the dilator has an elongated lumen extending therethrough for receiving an elongated guidewire and a luer-lock adapter may be provided at a proximal end of the dialator. Preferably, a T-shaped griping structure is operatively associated with the proximal end portion of the primary sheath, and the primary sheath includes diametrically opposed elongated score lines, or a similar frangible structure associated therewith, to facilitate separation of the primary sheath from the secondary sheath, and withdrawal of the primary sheath from the surgical site.
The subject invention is also directed to a method of implanting surgical devices through the surface of the skin. The method includes the initial step of providing a vascular introducer including an elongated primary sheath defining an interior lumen, an elongated secondary sheath disposed within the interior lumen of the primary sheath in a collapsed condition, and an elongated dilator disposed within the interior lumen of the primary sheath, where the lumen of the secondary sheath can have, in an expanded condition, a larger diameter than the lumen of the primary sheath. The method further includes the step of advancing the vascular introducer through the surface of, the skin to a desired position within a blood vessel, removing the dilator from the interior lumen of the primary sheath and introducing a first surgical device to the desired position within the blood vessel through the interior lumen of the primary sheath. The method further includes the step of separating the primary sheath from the secondary sheath, advancing the dilator through the interior lumen of the secondary sheath to move the secondary sheath into an open condition, and introducing a second surgical device to the desired position within the blood vessel through the interior lumen of the secondary sheath.
The method further comprises the steps of percutaneously inserting a cannulated needle into the desired area within the blood vessel, verifying the position of the needle under fluoroscopy and by observing fluid return, inserting a guidewire through the needle and into a desired area within the blood vessel and withdrawing the needle from the desired area. The method also includes the steps of threading the dilator over the guidewire to advance the vascular introducer to the desired area within the blood vessel, and then separating or displacing the primary sheath from the secondary sheath.
These and other unique features of the vascular introducer of the subject invention and the method of utilizing the same will become more readily apparent from the following description of the drawings taken in conjunction with the detailed of the preferred embodiments.